Intervenor: Vol 23. No 3 July - September 1998

Harvard University Denied a Canadian Patent on the Oncomouse

The Oncomouse case was an appeal to The Federal Court of Canada, Trial division, from a decision of the Canadian Commissioner of Patents dated August 4, l995, denying Harvard a patent for a genetically altered mouse (which it had produced) and for all other non-human mammals, which might be altered in the same way ( none of which it had produced.) Called the "oncomouse," the mouse was altered by the insertion of a gene which predisposes the animals to develop tumours, making them useful for scientific research.

Mr. Justice Marc Nadon reviewed the relevant Canadian law, including a 1982 Abitibi Co. Case which established that unicellular life, a yeast culture developed to treat pulp mill effluent, is patentable. He noted that an essential element in that finding is that the subject of the patent be reproducible at will, consistently, and with uniformity.The subsequent Connaught Laboratories case held that a bovine cell line was patentable. The judge also reviewed the decisions of courts at several levels including the Supreme Court of Canada in the Pioneer-Hi-Bred Case, in which the company was refused a patent for a new soybean variety developed through cross-breeding. Although the Supreme Court of Canada did not rule on the issue of patentability of life, refusing the patent on other grounds, the Federal Court of Appeal did find that the soybean was not an "invention" for the purposes of the Patent Act.

Harvard urged Justice Nadon to follow US law. In 1980, the US Supreme Court established in a split 5-4 decision in the Chakrabarty case that a patent could be granted for bacteria which could break down crude oil. However, Judge Nadon preferred the minority view which would have denied the patent in that case, with comments that it was the role of Congress, not the Court, to broaden or narrow the reach of patent laws, especially when the subject of the patent "uniquely implicates matters of public concern."

The central issue of the Harvard case was whether the Oncomouse is an invention within the Canadian Patent Act which provides in Section 2:

"Invention" means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter"

and in particular, whether it constitutes a manufacture or composition of matter within the Act.

The judge considered four questions in construing the term "invention."

1. Whether it is appropriate to examine the degree of the inventor's control over the creation of the claimed invention.

Harvard argued that the mouse is an invention if it carries the transgene, regardless of other characteristics of the mouse, and that since the presence of the gene can be verified with certainty by testing, the inventor has complete control over the relevant characteristic. However, the judge found that such testing is not an indicia of control, but merely a test of what already exists. Further, Harvard has created and received a patent for the process of inserting a gene into a mouse egg, but they have not invented the mouse. Since a mouse is a very complex form of life, it is "more difficult" to treat its production like that of chemical reactions , as was done regarding yeast in the Abitibi case. All characteristics of the mouse other than the transgene are present "completely independently of human intervention."

2. Is it appropriate to distinguish between human intervention and the laws of nature?

In Canadian patent law, anything which is merely a discovery of nature is not patentable; an inventive step must be involved. Since the insertion of the myc gene is the step that gives the mouse its utility for research use, Harvard is entitled to (and did receive) a patent for the creation of the plasmid and the process of injecting it into a fertilized mouse egg. However, the creation of the mouse itself is "a marriage between nature and human intervention."

Justice Nadon does not consider that Harvard is entitled to a patent over every descendant mouse possessing the gene, produced by mating transgenic mice with ordinary ones. That process is analogous to the cross-breeding that produced the soybean (in the Pioneer Hi-Bred case) and the results, given the complexity of the life form involved, are "infinitely variable and, in its detail, unknown." He adopts the words of the Federal Court of Appeal in Pioneer Hi-Bred finding the the mouse "cannot really be said, other than on the most metaphorical level, to have been produced from raw materials or to be a combination of two or more substances united by chemical or mechanical means." The judge is distinguishing between the human inventiveness in inserting a new gene and the "laws of nature" which produce the particular species, mouse, in accordance with a gestation process whose result is "infinitely variable and, in its detail, unknown."

3. What is the test of reproducibility in the present instance?

Section 27(3)(b) of the Patent Act requires that an invention must be reproducible to be patentable. However, the judge holds that Harvard, which is claiming the entire animal, cannot actually produce an animal except by ordinary breeding and "too much is left to luck and chance.". This is insufficient for patentability since the location, presence and quality of the gene are totally uncontrollable.

He says further that "if someone skilled in the art wanted to produce an oncomouse with the gene in a particular organ, he or she would only be able to do so if lucky." If he is referring to the fact that Mendelian principles of descent determine which descendants of the mice will carry the gene, his words are consistent with the description of the process provided by Harvard. If he means that the process leads to insertion of the gene in some organs only, he has misunderstood the science. A transgenic mouse will have the inserted gene in every cell and therefore, every organ.

4. Is it appropriate in determining whether something is patentable subject matter to make distinctions between higher and lower life forms?

Justice Nadon recalls the words of the Federal Court of Appeal in Pioneer Hi-Bred that

the common ordinary meaning of the words "manufacture" and "composition of matter" would be distorted if a unique but simple variety of soybean were to be included within their scope.

He then finds that the words apply equally to cross-breeding of mice. Further, he supports making a distinction between higher and lower life forms, recalling that the Supreme Court, in Pioneer Hi-Bred stated that it was more appropriately to be decided by the legislature. He also quotes the majority in the US Chakrabarty case who referred to the risks from biotechnology which had been brought to their attention, found that the court was "without competence to entertain them" and suggested that those concerns should be addressed to the political branches of government and not the courts.

Justice Nadon concludes that

"A complex life form does not fit within the current parameters of the Patent Act without stretching the meaning of the words to the breaking point, which I am not prepared to do. However, if Parliament so wishes, it clearly can alter the legislation so that mammals can be patented."

Comment: This decision has the effect of maintaining the status quo in Canada regarding life form patenting. Patents are available for single-cell life forms, including human cell lines, but not for higher life forms. I expect that Harvard will appeal, but this is not yet known. Two further appeals are possible: to the Federal Court of Appeal, and to the Supreme Court of Canada. Thus, the issue may remain in the Courts for several years.

In the meantime, the federal government must develop its position for the review of the Intellectual Property chapter of the WTO agreement, to begin in l999. The application of patenting rights to life forms, already a profound world controversy, will be a part of that review. In his decision, and in favouring the minority decision in Chakrabarty, Justice Nadon has handed the issue back to the federal government, which has the authority to amend the Patent Act. It may chose to act, or allow the matter to proceed through the courts.

CELA is planning a public discussion of this question, as part of preparation for the TRIPs review, to involve a broad range of people and groups.

Case list:

President and Fellows of Harvard College v. Commissioner of Patents, Federal Court of Canada, File: T-275-96; April 21, l998.

Re Application of Abitibi Co. (1982), 62 C.P.R.(2d) 81

Re Application for Patent of Connaught Laboratories (1982) 82 C.P.R.(2d) 32

Pioneer Hi-Bred v. Canada (Commissioner of Patents), [1987]3 F.C. 8 (Federal Court of Appeal) and [1989]1 S.C.R.1623) Supreme Court of Canada

Diamond, Commissioner of Patents v. Chakrabarty, (1980)206 U.S.P.Q.193